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International normalized ratio control and subsequent clinical outcomes in patients with atrial fibrillation using warfarin.

Publication ,  Journal Article
Guimarães, PO; Lopes, RD; Alexander, JH; Thomas, L; Hellkamp, AS; Hijazi, Z; Hylek, EM; Gersh, BJ; Garcia, DA; Verheugt, FWA; Hanna, M ...
Published in: J Thromb Thrombolysis
July 2019

We explored associations between INR measures and clinical outcomes in patients with AF using warfarin, and whether INR history predicted future INR measurements. We included patients in ARISTOTLE who were randomized to and received warfarin. Among patients who had events, we included those with ≥ 3 INR values in the 180 days prior to the event, with the most recent ≤ 60 days prior to the event, who were on warfarin at the time of event (n = 545). Non-event patients were included in the control group if they had ≥ 180 days of warfarin exposure with ≥ 3 INR measurements (n = 7259). The median (25th, 75th) number of INR values per patient was 29 (21, 38) over a median follow-up of 1.8 years. A total of 87% had at least one INR value < 1.5; 49% had at least one value > 4.0. The last INRs before events (median 14 [24, 7] days) were < 3.0 for at least 75% of patients with major bleeding and > 2.0 for half of patients with ischemic stroke. Historic time in therapeutic range (TTR) was weakly associated with future TTR (R2 = 0.212). Historic TTR ≥ 80% had limited predictive ability to discriminate future TTR ≥ 80% (C index 0.61). In patients with AF receiving warfarin, most bleeding events may not have been preventable despite careful INR control. Our findings suggest that INRs collected through routine management are not sufficiently predictive to provide reassurance about future time in therapeutic range or to prevent subsequent outcomes, and might be over-interpreted in clinical practice.

Duke Scholars

Published In

J Thromb Thrombolysis

DOI

EISSN

1573-742X

Publication Date

July 2019

Volume

48

Issue

1

Start / End Page

27 / 34

Location

Netherlands

Related Subject Headings

  • Warfarin
  • Treatment Outcome
  • Stroke
  • Predictive Value of Tests
  • Middle Aged
  • Male
  • International Normalized Ratio
  • Humans
  • Hemorrhage
  • Female
 

Citation

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Guimarães, P. O., Lopes, R. D., Alexander, J. H., Thomas, L., Hellkamp, A. S., Hijazi, Z., … Granger, C. B. (2019). International normalized ratio control and subsequent clinical outcomes in patients with atrial fibrillation using warfarin. J Thromb Thrombolysis, 48(1), 27–34. https://doi.org/10.1007/s11239-019-01858-1
Guimarães, Patricia O., Renato D. Lopes, John H. Alexander, Laine Thomas, Anne S. Hellkamp, Ziad Hijazi, Elaine M. Hylek, et al. “International normalized ratio control and subsequent clinical outcomes in patients with atrial fibrillation using warfarin.J Thromb Thrombolysis 48, no. 1 (July 2019): 27–34. https://doi.org/10.1007/s11239-019-01858-1.
Guimarães PO, Lopes RD, Alexander JH, Thomas L, Hellkamp AS, Hijazi Z, et al. International normalized ratio control and subsequent clinical outcomes in patients with atrial fibrillation using warfarin. J Thromb Thrombolysis. 2019 Jul;48(1):27–34.
Guimarães, Patricia O., et al. “International normalized ratio control and subsequent clinical outcomes in patients with atrial fibrillation using warfarin.J Thromb Thrombolysis, vol. 48, no. 1, July 2019, pp. 27–34. Pubmed, doi:10.1007/s11239-019-01858-1.
Guimarães PO, Lopes RD, Alexander JH, Thomas L, Hellkamp AS, Hijazi Z, Hylek EM, Gersh BJ, Garcia DA, Verheugt FWA, Hanna M, Flaker G, Vinereanu D, Granger CB. International normalized ratio control and subsequent clinical outcomes in patients with atrial fibrillation using warfarin. J Thromb Thrombolysis. 2019 Jul;48(1):27–34.
Journal cover image

Published In

J Thromb Thrombolysis

DOI

EISSN

1573-742X

Publication Date

July 2019

Volume

48

Issue

1

Start / End Page

27 / 34

Location

Netherlands

Related Subject Headings

  • Warfarin
  • Treatment Outcome
  • Stroke
  • Predictive Value of Tests
  • Middle Aged
  • Male
  • International Normalized Ratio
  • Humans
  • Hemorrhage
  • Female